Wearable breast pump system

ABSTRACT

A breast pump system comprises at least one wearable milk collection hub connected via an air line to a combined external air pump and control unit. Each milk collection hub comprises: (a) a breast shield made up of a breast flange and a nipple tunnel; (b) a flexible diaphragm that is configured to prevent milk from reaching the external air pump; (c) an outer shell that is configured to removably attach to the breast shield, such that, when attached, the breast shield and outer shell form a vessel for collecting milk; and (d) a diaphragm cap that is configured to be secured over the diaphragm, forms part of the front face of the outer shell, and includes a port connected to the air line.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.17/907,347, filed Sep. 26, 2022, which is the national stage ofInternational Application No. PCT/GB2021/050764, filed Mar. 26, 2021,which claims priority to GB Application No. 2004395.6, filed Mar. 26,2020, each of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The field of the invention relates to a wearable breast pump system.

2. Description of the Prior Art

A breast pump system is a mechanical or electro-mechanical device thatextracts milk from the breasts of a lactating woman.

Most portable breast pump solutions that include a discreet design arenot readily affordable for most parents. There is a need for a design ofa wearable breast pump system with a sleek and discreet design as wellas a lower price point.

A fully integrated wearable breast pump system is described inWO2018229504A1. The wearable breast pump system includes a housingshaped to fit inside a bra. The housing includes an air-pump that drivesa diaphragm to generate negative air pressure. The diaphragm is seatedon a diaphragm holder that is positioned away from a side of a breastshield flange.

A compact and hands-free human breast milk collection device that fitsinto a mother's existing nursing or standard brassiere is shown in thesystem of US20080262420A1. The hands-free collection device connects toan external regular pump via a vacuum hose that is also configured toapply a vacuum pressure to the internal volume of the collection device.The vacuum hose attaches to a stem located at a fixed position on thetop exterior surface of the collection device. The position of the stemis chosen so that the pump will not suction breast milk into theexternal pump. Because it would be inconvenient and difficult to connectthe vacuum hose to the stem located at the top of the device after thedevice has been placed on the breast, the vacuum hose has to be properlyconnected to the stem before the milk collection device is being placedon the breast.

A breast milk collection device is also shown in the system ofUS20180008758A1. The collection device attaches to a vacuum tube via anopening also located at a fixed position on the rim of the exteriorsurface of the collection device. The opening communicates with aninterior chamber including an inflatable/deflatable flexible barrierthat allows vacuum pressure to be applied to a breast. The flexiblebarrier housing that encloses the flexible barrier has an oval cone likeshape and is located at the top of the collection device.Disadvantageously, the position of the flexible barrier obstructs theline of sight to the interior of the collection device and to thenipple.

Wearable hands free breast pumps have entered the market, such as theFreemie cups system. The Freemie cup includes a flexible barrier thatsits on top of the cup, thereby obstructing the view of the interior ofthe cup and of the nipple. Further, the cup is also made of a fairlyopaque material, making it difficult to have a clear view of theinterior of the device and of the nipple and to achieve a correct nipplealignment.

In view of the above, there is a need for an improved way to provide aneasy and flexible connection between a suction tube and a wearable milkcollection device. There is also a need to provide an unobstructed viewof the interior chamber of the wearable milk collection device, in orderto achieve a correct nipple alignment and to ensure the system isproperly operating, such that milk is entering the interior of thedevice.

SUMMARY OF THE INVENTION

The invention is a breast pump system comprising at least one wearablemilk collection hub connected via an air line to a combined external airpump and control unit. The milk collection hub(s) each comprise: abreast shield made up of a breast flange and a nipple tunnel; a flexiblediaphragm that is configured to prevent milk from reaching the externalair pump; an outer shell that is removably attachable to the breastshield, such that the breast shield and outer shell, when attached, forma vessel for collecting milk, and the front face of the outer shellincludes a curved portion; a diaphragm cap that is configured to besecured over the diaphragm, and forms part of the front face or forwardfacing part of the outer shell, and includes a port connected to the airline.

This arrangement enables the air line to be connected to the front faceof the outer shell of the milk collection hub; prior art devicesposition the diaphragm and air line on the top of the milk collectionhub, which obscures the users view down into device, which in turn makescorrect nipple positioning difficult. By having a diaphragm cap thatforms part of the front face of the outer shell, the user's view downinto the device is not obscured by a diaphragm that sits over thenipple; correct nipple positioning is easier to achieve.

In one implementation, the diaphragm cap can be rotated against theouter shell to adjust the position of the air port and hence theposition and direction of the port and the air line connected to theport; this enables the user to readily adjust the position of the airline so that it lies comfortably under a bra or other clothing. Thediaphragm cap may also be removable from the outer shell; then, the usercan place the hub on the breast without the diaphragm cap, and withoutthe inconvenience of an air line connected to the air port. Once aproper nipple alignment is achieved, the diaphragm cap and connected airline can then easily be attached back onto the outer shell of the milkcollection hub.

BRIEF DESCRIPTION OF THE FIGURES

Aspects of the invention will now be described, by way of example(s),with reference to the following Figures, which each show features of awearable breast pump system that implements the invention:

FIG. 1A shows a wearable breast pump system, made up of a pair of milkcollection hubs, an air line and a separate combined control and airpump unit that is external to the milk collection hubs.

FIG. 1B shows the wearable breast pump system with the milk collectionhubs connected via the air line to the combined control and air pumpunit.

FIG. 2 shows a perspective front view of a milk collection hub.

FIG. 3 shows a perspective rear view of a milk collection hub.

FIG. 4 shows a back view of the milk collection hub.

FIG. 5 shows a perspective view of the milk collection hub without theouter shell and without the diaphragm.

FIG. 6 shows an exploded view of the milk collection hub.

FIG. 7 shows the diaphragm.

FIG. 8 shows a cross section of a milk collection hub in a relaxedstate.

FIG. 9 shows a cross section of a milk collection hub showing thediaphragm under maximum negative pressure.

FIG. 10 shows a perspective view of the removable diaphragm cap withoutthe air tube.

FIG. 11 shows a front view of the removable diaphragm cap connected tothe air tube.

FIG. 12 shows a perspective view of the removable diaphragm capincluding the rigid pressure part.

FIG. 13A shows other cross section views of a milk collection hub in arelaxed state, at mid point and under maximum negative pressure.

FIG. 13B shows other cross section views of a milk collection hubincluding the milk port in a relaxed state, at mid point and undermaximum negative pressure.

FIG. 14 shows a perspective view of the outer shell, without theremovable diaphragm cap.

FIG. 15 shows a side view of a milk collection hub.

FIG. 16 shows a top down view of the control and air pump unit for thebreast pump system.

FIG. 17 shows a top down view of the control and air pump unit, with theupper case of the unit removed.

FIG. 18 shows an exploded view of the control and air pump unit.

FIG. 19 shows the components of the pump unit subsystem.

FIG. 20 shows a cross section of the airflow block inside the controlunit.

FIG. 21 shows a cross section of the airflow block inside the controlunit.

FIG. 22 shows a cross section of the airflow block inside the controlunit.

FIG. 23 shows the sound valve.

FIG. 24 shows a plot of the pumping cycle.

FIG. 25 shows schematics of the pump unit subsystem illustrating thepumping cycle.

FIG. 26 shows cross-sections of the control unit including the pump unitsubsystem illustrating the pumping cycle.

FIG. 27 shows a cross section of the control unit including pump unitsubsystem.

FIG. 28 shows a table listing different examples of vacuum levels.

FIG. 29 shows diagrams of a control unit including a multifunctionmount.

FIG. 30 shows pictures of a control unit including accessories.

FIG. 31 shows diagrams of a control unit including a multifunctionmount.

FIG. 32 shows the tube connection.

INDEX

Air line leading to milk collection hub 1 Air line leading to milkcollection hub 2 Air line leading from combined control and air 3 pumpunit Milk collection hub 10 Combined control and air pump unit 11 Airtube connection component 12 User interface on the control and air pumpunit 13 Air port or hole in the control and air pump unit 14 Air port orhole in the diaphragm cap 15 Outer shell of a milk collection hub 20Breast shield 21 Diaphragm cap 22 Cover to milk opening 23 Milk quantityscale on the shell 24 Finger grip features 30 Nipple tunnel part of thebreast shield 31 Flange of the breast shield 32 Guide lines on thebreast shield 33 Milk hole in the nipple tunnel 41 Milk non-return valve51 Second milk hole 52 Diaphragm housing 53 Diaphragm housing, annularrear wall 54 Diaphragm housing, cylindrical outer wall 55 Diaphragmhousing, cylindrical inner wall 56 Diaphragm housing, front wall 57Diaphragm 61 Seal between breast shield and outer shell 62 Diaphragm,annular rear wall 63 Diaphragm, cylindrical outer wall 64 Diaphragm,cylindrical inner wall 65 Diaphragm, front wall 66 Central axis throughthe nipple tunnel 81 Pressure chamber in a relaxed state 82 Pressurechamber under maximum negative 83 pressure Pair of chambers in thediaphragm cap 84 Illustration of end-user breast area 85 Rigid pressurechamber part 91 Ball bearings 100 Cross section in relaxed state 101Cross section at mid point 102 Cross section at maximum pressure 103Milk pouring opening 111 Flat portion of the diaphragm cap 120 Dualfunction pump/pause button 130 Power on/off button 131 Button to switchthe pumping profile 132 Pressure decrease button 133 Pressure increasebutton 134 Pressure level visual indicator LEDs 135 Pumping profilevisual indicator LEDs 136 Battery status LED 137 USB-C charging socket138 Chassis 140 Upper case 151 Lower case 152 PCB 153 Air pump unitsubsystem 154 Rechargeable battery 155 Pump unit 161 Solenoid air bleedvalve 162 Sound attenuating motor mount 163 Airflow block 164 Solenoidfoam cap 165 Sound valve 166 Sound valve cap 167 Solenoid valve inlet171 Solenoid valve outlet 172 Seal member 173 Motor exhaust 181 Tubewrap accessory 241 Battery accessory 242 Milk drawn from nipple intochamber 251 Removable waistband clip 261 Tube splitter 261 Bung orstopper in the tube splitter 262 O-ring 290 Control unit and o-ring inportrait mode 291 Control unit and o-ring in landscape mode 292 Firstphase of pumping cycle (pumping time) P Second phase of pumping cycle(bleed time) B

DETAILED DESCRIPTION

An implementation of the invention is a breast pump system forextracting and collecting breast milk. The system comprises a pair ofmilk collection hubs 10, a combined control and air pump unit 11, and anair tube connection component 12, as shown in FIG. 1A. In normal use, asshown in FIG. 1B, air tubes 1, 2 connect each milk collection hub 10 tothe air tube connection component 12; the air tube connection component12 connects air tubes 1, 2 to a single air tube 3, that in turn leads tothe control and air pump unit 11.

The milk collection hubs may also be connected to any external controland air pump unit, including any external regular electric or manualcontrol and air pump unit.

An intended use case involves the user placing either one or two milkcollection hubs 10 onto their breast(s), connecting one or bothcollection hubs to the combined control and air pump unit 11 via the airtubes 1, 2 and 3 and the tube connection component 12.

The user controls the device using a user interface 13 located on thecontrol unit 11. Starting the breast pump system, via the user interface13, activates an air suction pump within the control and air pump unit11 (also referred as control unit). An air port or hole 14 on thecontrol and air pump unit 11 connects to a tube 3 which splits via atube splitter in the air tube connection component 12 into two tubes 1,2, which then deliver suction to the milk collection hubs 10 via airports or holes 15 in each milk collection hub 10. When the pump in unit11 is activated, negative air pressure is created between the controlunit 11 and the milk collection hub(s) 10, thereby applying negativepressure to the nipple, drawing milk from the breast, and collecting itinside the milk collection hubs 10.

The breast pump system can be operated using either one (single pumping)or two (double pumping) milk collection hubs 10. The breast pump systemcan generate pressures in the range of 150 to 350 mmHg depending on thelevel of stimulation selected by the user.

FIGS. 2 and 3 show perspective views of a milk collection hub. The milkcollection hubs 10 are both identical and are configured to be discreetand to be comfortably held inside a bra, with the outer shell 20 havinga curved shape that is configured to contact the inner surface of thebra. The outer shell 20 fits or latches onto a breast shield 21 thatforms the rear surface of the hub 10. The breast shield 21 is made up ofa breast flange 32 and a nipple tunnel 31; the interior volume betweenthe outer shell 20 and the breast shield 21 defines a chamber in whichmilk is collected. The breast flange 32 contacts the user's breasts. Theouter shell 20 is directly removable from the breast shield in normaluse or normal dis-assembly to enable cleaning of the interior volume inwhich milk is collected.

The outer shell 20 also includes a removable diaphragm cap 22 thatcovers and seals a diaphragm located inside the milk collection hub. Thediaphragm cap 22 is located at the front of the outer shell 20, andforms a central region on the front surface of the outer shell 20. Thediaphragm cap 22 includes the air port or hole 15 which provides the airconnection to the control unit 11 via a tube. Because the diaphragm cap22 is positioned at the front of the outer shell 20, it does not blockthe user's view down through the transparent outer shell 20 into theinterior of the milk collection hub; it hence enables the user to seewhether the collection hub 10 is correctly positioned on a breast andwhether milk is being successfully expressed into the collection hub 10.

The diaphragm cap 22 is easily removable with one hand from the outershell 20 of the hub in normal use or normal disassembly. Because the airline 1, 2 is connected to the air hole 15 in the diaphragm cap 22,removing the diaphragm cap 22 from the outer shell 20 provides a robust,easy, quick release of the suction connection between the hub 10 and thecontrol unit 11, and, similarly, a robust, easy, quick installation ofthe suction connection between the hub 10 and the control unit 11.Generally, air lines 1, 2 remain fixed to their respective diaphragm cap22, so the user does not have to worry about the potentially difficultprocess of attaching the air lines to the air port 15 in each collectionhub 10.

The removable diaphragm cap 22 can be rotated against outer shell 20 toadjust the position of the air port on the outer shell and hence theposition and direction of the air lines 1, 2; this enables the user toreadily adjust the position of the air lines 1, 2 so that they liecomfortably under a bra or other clothing. The user can place the hub 10on the breast without the diaphragm cap and without the inconvenience ofan air tube 1, 2 connected to the air port 15. Once a proper nipplealignment is achieved, the diaphragm cap 22 and connected tube caneasily be attached on the hub 10.

In FIG. 3 , the breast shield 21 includes a nipple tunnel 31 shaped toreceive a nipple and a flange 32. Preferably, the breast shield 21including the flange 32 and the nipple tunnel 31 is a single piece itemmade of a single moulding with a single smooth internal surface. Thereare no joins along the nipple tunnel; joins may aggravate the delicatenipple tissue as the nipple extends and contracts during pumping.

The breast shield 21 may be configured to slide onto the outer shellusing a single push action. The breast shield 21 and outer shell 20 mayalso attach using magnets.

Preferably, the breast shield 21, and the outer shell 20 and thediaphragm cap 22 are all substantially rigid and optically clear orsubstantially transparent, e.g. in order to provide an unobstructed viewof the nipple and the inside of the hub 10. The breast shield 21, thediaphragm cap 22 and the outer shell 20 may for example all be madesubstantially of clear, rigid, dishwasher-safe material such aspolypropylene, or a polycarbonate, or a co-polyester like Tritan™, orinclude sections of those materials sufficient to enable the user toclearly see inside the milk collection hub 10. Being dishwasher-safe isimportant as it enables these components to all be easily cleaned in anormal dish-washing cycle. This also allows different components of thewearable breast pump system to be easily washed and/or sterilised. Thisrigidity and transparency helps achieve correct nipple alignment whenplacing the entire milk collection hub 10 onto the breast, as well as toenable the user to readily check whether the alignment is maintainedwhile pumping. Milk collection hubs made of very flexible silicone canbe harder to correctly position on breast. The nipple tunnel is alsoclearly visible to the user through the substantially transparent wallsof the hub 10, further ensuring that the spacing between the nipple andthe side walls of the nipple tunnel 31 is correctly maintained whilepumping.

During a pumping session, the user is also able to view the inside ofthe milk collection hub 10 and is able to ensure milk is being expressedinside the hub 10 and have an indication of the level of collected milkinside the hub. A scale 24 located on the outer shell 20 indicates thevolume of milk inside the hub 10.

The breast shield 21 may also include guide lines 33 running parallel tothe sides of the breast shield in order to help with nipple alignment;these guide lines 33 are designed to be positioned generallyhorizontally in use, and to be easily seen by the user when looking downat the breast shield 21 when positioned on breast; the lines enable theuser to correctly position the breast shield 21 so that the nipple ispositioned generally along the centre-line leading through the nippletunnel (e.g. central axis 81 shown in FIG. 8 ).

The outer shell also includes a milk pouring opening which can be closedusing a removable part 23 to cover the milk pouring opening duringpumping and general handling.

The breast shield 21 and/or outer shell 20 may be made of asubstantially rigid polypropylene material, or a polycarbonate or aco-polyester material such as the Tritan material that is opticallyclear and dishwasher safe. The material may be particularly chosen as abalance of cost and acceptable achievable transparency.

FIG. 4 shows a back view of the milk collection hub. As shown, thenipple tunnel 31 includes a milk hole 41 through which expressed milkflows onto the milk collection hub. Guide lines 33 are positioned abovethe central axis of the nipple tunnel 31 and are not aligned with thatcentral axis; this compensates for the slight parallax arising whenviewing the guide lines 33 and nipple from above.

FIG. 5 shows a perspective view of the one-piece, rigid breast shield 21but without the outer shell and without the diaphragm. Breast shield 21includes an annular diaphragm housing 53; diaphragm housing 53 has anouter, approximately cylindrical side wall 55 that is generally parallelto the nipple tunnel 31, and a generally concentric, approximatelycylindrical inner side wall 56 that forms the outer wall of the nippletunnel 31. Diaphragm housing 53 has a front wall 57 that forms the endof the nipple tunnel; it also has an annular rear wall 54 that joins theconcentric inner wall 56 and the outer wall 55.

FIG. 8 provides a cross-section showing these features. A flexiblemembrane 61 (see FIGS. 6-9 and FIGS. 13A and 13B) sits flush againstthese walls of the annular diaphragm housing 53 in the relaxed state(i.e. when no negative air pressure is applied) and hence has a similarshape, with a generally cylindrical outer membrane wall 64 that sitsflush against housing cylindrical outer wall 55; a concentric innermembrane wall 65 that sits flush against housing cylindrical inner wall56; a front wall 66 that sits over the end of the housing front wall 57that forms the end of the nipple tunnel; and an annular rear wall 63that sits flush against the diaphragm housing rear wall 54.

Diaphragm cap 22 sits over the flexible diaphragm or membrane 61 and anegative pressure chamber is hence formed between diaphragm cap 22 andone side of the flexible diaphragm 61. The diaphragm 61 hence moveswithin an air-pump chamber formed on one side by the diaphragm housing53 and on the other side by the diaphragm cap 22; flexible diaphragm 61is pulled forwards, along the direction of central axis 81, movingthrough this negative pressure chamber when suction is applied. As theflexible diaphragm 61 is pulled forwards, it creates a low air pressureregion on the other side of the flexible diaphragm 61, i.e. the sidebetween the flexible diaphragm 61 and the diaphragm housing 53. This inturn reduces the air pressure inside the nipple tunnel 31, since milkhole 41 in the nipple tunnel 31 ensures air pressure equivalence betweenthe inside of the nipple tunnel 31 and the inside of the diaphragmhousing 53; the pressure reduction draws the nipple forward and causesmilk to be expressed from the nipple. Milk passes through the milk hole41 of the nipple tunnel 31, and then passes through a second milk holeor opening 52 located on the diaphragm housing 53, and then flows insidethe collection hub via a non-return valve 51 that is mounted on thesecond milk hole or opening 52. The non-return valve enables milk topass into the milk container in one direction. Note that the diaphragmhousing 53, and hence the diaphragm 61, is placed towards the end of thenipple tunnel 31, away from the breast shield 21. Diaphragm 61 in factextends over the end of nipple tunnel 31. This structure has the benefitof giving the user a clearer view down through the nipple tunnel 31 whenpositioning the nipple inside the nipple tunnel 31: if the diaphragmhousing 53 were closer to the breast shield 21, then that view would beblocked. The downside however is that the milk collection hub 10 is notcompact in the direction of the nipple tunnel and is shaped to fitinside an inner portion of a bra.

Preferably, the non-return valve is removable for easy cleaning.

When the outer shell 20 is fitted on the breast shield 21, thecollection hub forms a vessel in which milk is collected after it passesthrough the non-return valve with a capacity to collect approximately 5fluid ounces (148 ml).

The hub also includes a vent hole located for example at the top of theouter shell such that atmospheric pressure is maintained inside thevessel, even during negative pressure cycles.

FIG. 6 shows an exploded view of the milk collection hub 10. In thisexample, the wearable milk collection hub 10 comprises the followinguser-removable parts: the breast shield 21, the outer shell 20, thediaphragm 61 and the diaphragm cap 22. The diaphragm cap 22 fits overwith an air-tight seal to the flexible diaphragm 61. An air tight sealbetween the breast shield 21 and outer shell 20 is provided by aremovable seal member 62.

The flexible diaphragm 61 may either be fully removable from the hub 10or may form an integral part of the outer shell 20. When it isremovable, it push-fits into the outer shell 20, forming an air andliquid tight seal. When it is an integral part of the outer shell, theflexible diaphragm 61 is typically laser welded at its single outer,circular edge, to a single, circular edge in the outer shell 20.

As noted above, the breast shield 21 includes a diaphragm housingportion 53, in which the flexible diaphragm 61, can move in and out,when assembled. The diaphragm housing portion 53 includes an air holethat transfers negative air pressure to the nipple tunnel 31; this maybe the milk hole 41 in the nipple tunnel 31 or another hole (not shown).The diaphragm 61 flexes when negative air pressure is applied to it bythe external air pump unit subsystem located in the control unit andtransfers negative air-pressure to pull the breast and/or nipple againstthe breast shield and apply suction to the nipple, to cause milk to beexpressed.

FIG. 7 shows the diaphragm 61 in side view and also perspective view.The diaphragm 61 is configured to prevent milk from reaching the pumpunit housed inside the control unit 11.

The overall dimensions of the diaphragm are about 77.3 mm in diameterand 24 mm in height (ie depth along the long axis 81 of the nippletunnel). The volume of air displaced by the diaphragm when under maximumsuction is approximately 17550 mm³. Typical variants may have dimensionsthat are ±25% of these dimensions.

The shape of the diaphragm 61 is not a substantially flat or ridged,convex membrane, as for example found in the Elvie Pump. Instead, it hasan outer, approximately cylindrical side wall 64 that is generallyparallel to the nipple tunnel 31, and an inner, approximatelycylindrical side wall 65 that is also is generally parallel to thenipple tunnel 31. Diaphragm 61 has a front wall 66 that caps the innerside wall 65 and lies over the end of the nipple tunnel 31. It also hasan annular rear wall 63 that joins the outer and the inner sides walls64, 65.

FIG. 8 is a cross section of a breast 85 inserted inside a milkcollection hub in a relaxed state, showing the diaphragm 61 in relationto the axis of the nipple tunnel 81, milk port 41 and the pressurechamber 82. The flexible diaphragm 61 includes outer side wall 64 andinner side wall 65, which each substantially run parallel to the centeraxis of the nipple tunnel 81, and some portions, which substantially runperpendicular to the center axis of the nipple tunnel 81. Asillustrated, the diaphragm 61 includes inner annular wall 63 and end capwall 66 which are perpendicular to the centre axis 81. Much of theflexible diaphragm 61 lies over milk port 41 and also to the right (i.e.away from the breast) of the milk port 41. Milk collection hub 10 istherefore not designed to be compact in the direction of the axis of thenipple tunnel 81. Further, inside the nipple tunnel, the entire volumeor space to the right of the nipple and breast is subject to negativepressure; the negative pressure zone hence starts at the skin/airboundary and so flexible diaphragm 61 is entirely to the right (i.e.away from the breast) of the negative pressure zone that is adjacent tothe breast. Again, this leads to milk collection hub 10 not beingcompact in the direction of the axis of the nipple tunnel 81. But thatcompromise is necessary in order to give the user a clear view downthrough the clear material of the breast shield 21 nipple and outershell 20 so that the nipple can be correctly positioned within nippletunnel 31: correct positioning is very important for comfort and alsoeffective milk expression.

FIG. 9 is a cross section of the breast 85 inserted inside a milkcollection hub showing the diaphragm 61 under maximum negative pressure.During a negative air pressure phase the flexible diaphragm 61 flexesand moves towards the right; even the rear wall 63 moves past the milkport 41. The central section 66 of the diaphragm 61 is at all timeslocated substantially to the right of (i.e. extending beyond) the end ofthe nipple tunnel 31. During suction, the central section 66 also movesforward into a pair of chambers 84 in the diaphragm cap 22; thisadditional movement of the diaphragm 61 contributes significantly to thesuction achieved inside the nipple tunnel, and hence the milk pumpingefficacy.

The diaphragm 61 and associated diaphragm cap 22 are also positioned atthe front of the hub 10 so as not to obstruct the mother's view of thenipple when placing the collection hub 10 onto her breast.

FIG. 10 shows perspective views of the removable diaphragm cap 22. Thediaphragm cap 22 includes a pair of hollow or recessed finger gripfeatures 30, making it easily handled using only two fingers. Thediaphragm cap 22 is easily rotated so as to adjust the position of theair port 15 and hence the position of air tube 1, 2 (not shown) thatwould be connected to the air port 15.

FIG. 11 shows a front view of the removable diaphragm cap 22 connectedto an air tube 1. The air tube 1 may pass through a passage way locatedat the center of the diaphragm cap 22, providing an additionalprotection for the air tube 1 so that it is not, in use, easily pulledout, and so that the direction of the tube 1 conforms with the surfaceof the inner bra. The diaphragm cap 22 may also be configured to attachto the outer shell 20 by means of a latch system. The diaphragm cap 22may latch into the outside shell when spring plungers, such as ballbearings 100 in the diaphragm cap, locate into small indents in theouter shell 20. An audible and/or haptic feedback may confirm that theremovable diaphragm cap 22 and air tube 1 are properly assembled.

FIG. 12 shows a side view of the removable diaphragm cap 22 including anadditional rigid part 91. The additional part 91 is removable from thediaphragm cap 22 and is also shown in isolation. Alternatively, theadditional part 91 may be an integral part of the diaphragm cap 22.Additional part 91 reduces the volume of the pump chamber and henceleads to an improved pumping efficiency.

FIG. 13A shows cross sections of a breast 85 inserted in the milkcollection hub 10 including the additional rigid part 91 located in thepressure chamber. FIG. 13B shows similar cross sections of the milkcollection hub, but without the nipple. Note that the nipple sizing isapproximate and that there are considerable variations in nipple sizeand in how nipples extend when under suction. Note also that thesedevice cross sections are just one example and commercially availabledevices may differ. Diaphragm 61 is positioned over the end of nippletunnel 31 and extends beyond the milk port 41 in the direction of axis81 for the reasons given earlier, namely to provide a clear view of thenipple in the clear nipple tunnel 31. Cross sections illustrate thediaphragm 61 movements from a relaxed state 101, to a mid-point 102 andfinally under maximum suction 103. The diaphragm 61 is shown in arelaxed state, in relation to the axis of the nipple tunnel 81, milkport 41 and the pressure chamber. The rigid pressure chamber part 91reduces the volume of air inside the pressure chamber by limiting themovement of the diaphragm 61 under negative pressure, for example byblocking the pair of chambers 84 in the diaphragm cap 22. The centralsection 66 of the diaphragm 61 is at all times located substantially tothe right of (i.e. extending beyond) the end of the nipple tunnel 31.When suction is applied, the member 61 moves forward along the directionof the central axis 81 of the wearable hub through the negative pressurechamber, as shown in the mid-point illustration 102. The diaphragm 61becomes flush with the rear surface of the rigid pressure chamber part91 when it is fully displaced under maximum negative pressure.

In this configuration, by minimizing the volume of air in the pressurechamber, a faster response time and faster cycle time is achieved forsingle and double pumping, as well as greater peak negative pressure. Inone implementation, using single pumping, the minimum pressure is 50mmHg at cycle time of 75 cycles/min, and the maximum pressure is 350mmHg at cycle time 30 cycles/min. Using double pumping, the minimumpressure is 30 mmHg at cycle time of 75 cycles/min and the maximumpressure is 280 mmHg at cycle time 30 cycles/min.

FIG. 14 shows a perspective view of the outer shell 20 including themilk pouring opening 111.

FIG. 15 shows a side view of a milk collection hub. The overall widthdimension of the milk collection hub 10 along the central axis of thenipple tunnel is about 5.7 cm; it is not designed to be particularlythin or compact in the direction of the axial arrow and has a widthdimension that is similar or greater than earlier breast collectionhubs, such as the Playtex Embrace™. The milk collection hub 10 includesa flat portion 120 located on the diaphragm cap 22, so that the entiremilk collection hub 10 can rest on a flat surface with the breast shield21 uppermost.

Alternatively, the milk collection hub 10 may also include a flatportion on the base of the outer shell 20 such that the entire milkcollection hub 10 can rest on a flat surface with the milk opening 111uppermost.

Control Unit

The control unit 11 is configured to generate negative air pressure forthe breast pump system. The control unit 11 has a discreet form and isshaped to comfortably fit in the palm of the hand and be readily grippedby a single hand.

The control unit 11 is shaped to fit inside a pocket (or even a bra).Preferably, the control unit is less than 120 mm in length, less than 70mm in width and less than 45 mm in height. Preferably, the control unitis less than 0.2 kg.

A user interface 13, provided on the control unit 11, may includebuttons, haptic feedback, sliders, any form of display, lights, or anyother componentry necessary to control and indicate the use of thebreast pump system. The user interface is configured to be intuitive andeasy to use.

A particular example of the user interface 13 is provided in FIG. 16showing the top view of the control unit 11. A power on/off button 131powers on or off the breast pump system. One button 132 switches thepumping profile, such as between stimulation or expression modes. Thebuttons 133 and 134 adjust the pressure generated by the pump and hencethe vacuum pressure applied to the user's breast(s). A dual functionpump/pause button 130 is also provided for the user to interrupt thepumping process without turning the device off.

A visual indicator includes a series of LEDs 135 that change appearance,with more LEDs being illuminated, as the pressure generated by the pumpincreases. Another visual indicator includes an LED 136 that changesappearance when the pumping profile changes. For example, one colorindicates stimulation and another color indicates expression. As anotherexample, the LED is turned off to indicate stimulation and is on toindicate expression. Another visual indicator includes an LED 137 thatindicates the battery status. For example, the color red indicates lowbattery; orange indicates that the battery is charging; while greenindicates when the battery is fully charged.

The battery is a rechargeable battery which can be charged via USB.Hence the control unit includes a USB charging socket 138 fortransferring power to a power charging circuit housed inside the controlunit.

The information provided through the user interface may also besupplemented by or alternatively conveyed solely through hapticfeedback. The user interface may also take the form of a touchscreen.

FIG. 17 shows the control unit with the upper case removed. The visualindicators 135 136 and 137 including LEDs are mounted or attached on thechassis 140.

FIG. 18 shows an exploded view of the control unit U with some of thekey internal elements. The outside surface of the control unit is madeof an upper case 151 and a lower case 152, which when assembled togetherare adapted to house, hold and protect the internal components of thecontrol unit 11.

The control unit 11 houses an air pump unit subsystem 154 for generatinga negative pressure in the milk collection hub(s), as well as a battery155 and control electronics on PCB 153. The chassis 140 holds in placethe main components such as the air pump unit 154, the battery 155 andthe PCB 153. The chassis also includes the actuators between the userinterface and the PCB switches.

The breast pump system has been configured to deliver quiet operation innormal use. In particular, the control unit has been configured to bothreduce motor vibration and attenuate sound from the pump unit subsystem154.

The components of the pump unit subsystem 154 are shown in FIG. 19 . Apump unit 161, including a pump driven from a motor, is configured togenerate negative air pressure. The pump unit 161 is connected to ableed valve, such as a solenoid valve 162 that is configured to resetthe system to ambient pressure when the motor stops.

Reduction of Motor Vibration and Attenuation of Sound

The breast pump system is designed to be more discreet compared toavailable solutions with respect to volume and sharpness of noise. Thisis enabled by one or more of the following: reducing the sound generatedby the pump unit 161; soundproofing the control unit 11; reducing thepower of the pump unit 161, reducing the bleed sound by slowing down theairflow speed during rapid return to ambient air pressure after eachpumping cycle, and absorbing the vibration of the pump motor in the pumpunit subsystem 154.

The motor vibrations are reduced by holding the pump unit 161 in placebetween two silicone parts: a sound attenuating motor mount 163 and anairflow block 164. The sound attenuating motor mount 163 holds the backof the pump motor and absorbs part of the vibration of the pump motor.The airflow block 164 includes an air port or hole for routing theairflow from the pump unit 161 to the tube connector 14 and also absorbspart of the vibration of the pump unit. By using the two silicone parts,the vibration transmitted to the hard plastic case 151, 152 is greatlyreduced and hence the unit is significantly quieter than other pumpingunits; a major advantage when discretion is sought, and to reducedisturbance to baby.

Both the sound attenuating motor mount 163 and the airflow block 164 areone-piece items made of either compression-moulded or ISR mouldedsilicone.

FIGS. 20 to 22 provide cross sections of the airflow block thatillustrates the air paths inside the airflow block. The airflow block164 is a multifunctional block that:

-   -   routes or directs the airflow from the tube connector 14 or        inlet to the pump unit 161 (see FIG. 20 ).    -   directs the air from the motor exhaust 181 to the atmosphere        through a simple straight hollow tube with an exit path at one        end (see FIG. 21 ).    -   provides the mounting for the solenoid valve inlet 171 and        outlet 172 (see FIGS. 20 and 22 ).    -   provides an isolation barrier for motor vibrations.

The airflow block 164 therefore is configured to both attenuate soundand to reduce motor vibration.

A number of components may be used to further reduce the sound generatedby the pump unit subsystem including, but not limited to:

-   -   A solenoid foam cap 165 to reduce bleed flow as well as bleed        sound.    -   A sound valve 166 (as shown also in FIG. 23 ) located in the        lower portion of the case 152. The sound valve 166 allows the        internal pressure of the control unit 11 to remain at ambient        pressure without high levels of sound escaping from the control        unit 11. A sound valve cap 167 is also used to protect the sound        valve 166 from the external environment.    -   Sealing the control unit 11 so as to further attenuate sound.        For example, a seal member 173 (see FIG. 23 ) is included in        between the upper part 151 and lower part 152 of the case,        around the periphery of the control unit 11, hence allowing no        air to escape from the control unit 11, to reduce the pump unit        161 sounds from travelling outside the control unit 11.        Optionally, the airflow block 164 may also be integrated with a        portion of the seal member 173.    -   Mufflers or silencers can also be used reduce the airborne noise        emitted from air inlets and/or exhausts. One silencer can be        connected to the solenoid 162 and another silencer can be        connected to the pump motor.

The sound valve 166 located on the lower part 152 of the case is shownin FIGS. 19 and 23 . The sound valve 166 is a silicone part configuredto deform under pressure. Hence it allows the air to pass in and out ofthe control unit 11, whilst significantly attenuating the motor and pumpnoise from travelling out of the control unit 11. The sound valve 166also ensures that the inside of the control unit 11 remains at ambientpressure and that the pump unit 161 is working in the right conditions.

The sound valve may include a small cross section cut.

The pumping cycle is now described in FIGS. 24 to 26 .

Once the system is activated, a pumping cycle begins: the air-pressurepump turns on and creates negative air pressure during a first phase ofthe pumping cycle, referred to as the pumping time (P). When negativeair pressure is applied to the milk collection hubs 10, the flexiblediaphragm 61 flexes and negative air pressure is conveyed to the insideof the nipple tunnel 31, to pull the breast and/or nipple, thus drawingmilk 251 from the nipple. During this first phase of the pumping cycle(P), the air-pressure pump 161 is configured to be on for a pre-definedamount of time in order to provide a target negative air pressure.During this first phase, the solenoid valve 162 is configured to beturned off.

After the target negative air pressure has been reached, theair-pressure pump 161 turns off, and air is bled into the system via thesolenoid valve 162 during the second phase of the pumping cycle referredto as bleed time (B). At the end of the bleed time, the system istherefore reset to ambient pressure.

During this second phase of the pumping cycle, the solenoid valve 162opens to reset the pressure in the milk collection hubs 10 to ambient,which causes a rush of air into the solenoid valve 162 and generates asound, such as a sharp, high frequency sound. As discussed above, usinga solenoid foam cap 165, as shown in FIG. 27 , reduces the rush of airentering the solenoid valve 162 and therefore reduces the overall soundgenerated by the solenoid valve 162. The solenoid foam cap 165 includesone or more small openings or holes that are configured to reduce andcontrol air speed when entering the solenoid valve 162. The solenoidfoam cap 165 may be a one-piece item made of plastic.

The pumping cycle may be programmed to follow different modes, such as astimulation mode and an expression mode, by controlling the pumping timeand the bleed time. The pumping cycle and/or modes may also beprogrammed to reach different vacuum levels.

Stimulation mode is configured to encourage milk flow and expressionmode is configured to maximize pumping efficiency. Each mode contains anumber of different vacuum levels, such as 10 different vacuum levels,which can be selected via the user interface on the control unit.

FIG. 28 lists an example of 10 different vacuum levels for stimulationand expression modes and for single and double pumping. This is oneexample and commercially available devices may differ. Adjusting thepower delivered to the pump motor also reduces the sound generated bythe system.

Hence a desired vacuum level and sound for a particular mode may beachieved by controlling the time of both phases of the pumping cycle andthe power delivered to the pump motor.

The perimeter of the control unit has a complete seal 173 (see FIG. 23), dramatically reducing the airborne noise leaving the unit. This sealcreates a significantly quieter product for the user.

Overall, in operation, the noise level is less than 50 dB and preferablyless than 45 dB.

A number of removable accessories may be used that attach to the controlunit 11 to improve the user experience. These may include for example:

-   -   a removable, auxiliary battery pack for increasing the length of        time a user can pump for between charges.    -   a tube wrap device that clips to the back of the control unit,        allowing the user to neatly store the tubes by wrapping them.        This may also allow the user to customise the length of their        tubes during use.    -   a belt clip that allows the user to attach the control unit to        their clothing, wearing it on their waistline or elsewhere.    -   a lanyard that clips to the control unit, allowing the user to        wear the control unit by hanging it around their neck.

The attachment method for accessories may involve an O-ring style loopthat stretches over the control unit in multiple positions, allowing acontrol unit to be mounted in either portrait or landscape orientation.

Accessories for the Control Unit

The control unit may also include a number of easily removableaccessories.

FIG. 29 shows diagrams of a control unit 11 including a multifunctionmount such as an O-ring 290. The multifunction mount enables the controlunit 11 to be easily held by the user's fingers in different modes, suchas portrait 291 or landscape mode 292.

FIG. 30 shows pictures of the control unit 11 including a tube wrapaccessory 241 located under the bottom case of the control unit 11, andof the control unit including a battery accessory 242 located under thebottom case of the control unit 11, such as a battery pack.

FIG. 31 shows a picture of a control unit 11 including an o-ring 290mount extending around a periphery of the control unit 11. The mountincluding a removable waistband clip 261 enabling the control unit tobe, for example, clipped to a belt or trousers.

Tube Connection

FIG. 32 shows the tube connection 12 including the tube splitter 261.The tube splitter 12 in effect splits the air line 3 that comes from thecombined control and air pump unit 11 into two separate air lines 1, 2that attach to the two milk collection hubs 10. Tube splitter 12attaches to one end of the air lines 1, 2 that are connected at theirother end to the air port 14 in each milk collection hub 10. The tubesplitter attaches to one end of the air line 3 that is connected at itsother end to the combined control and air pump unit 11. Tube splitter 12includes a bung or stopper 262 that can be rotated in order to configurethe breast pump system for single pumping or double pumping, by creatingan air path that leads from air line 3 into either the left airline 1 orthe right air line 2 to activate respectively just the left hub or theright hub; or it can create an air path that leads from air line 3 intoboth left airline 1 and also right air line 2, for double pumping.

Application Running on a Connected Device

Pump system related data may be sent by the system to a connectedsmartphone or other computer device. The data may be further analysed bya data analysis subsystem. The data may also be displayed on anapplication running on the computing device.

The application may provide one or more of the following features:

-   -   Discreet/Remote control of device, such as: play/pause, mode        change, intensity setting change.    -   Battery life indication.    -   Session time and date tracking.    -   Milk volume tracking.    -   Integration with other devices, such as other breast pump        system.

APPENDIX 1

Key features of the breast pump system are now generalized into thefollowing categories:

A. User experience: Nipple Visibility

B. Cost Engineering: Simplicity

C. User Experience: Low Noise

D. User experience: Product Handling

Note that any feature can be combined with any one or more otherfeatures. The invention is however defined in the appended claims. Notefurther that, whilst the implementation described above is a breast pumpsystem with one or two in-bra wearable milk collection hubs, eachconnected to an external air pump, it is possible to integrate an airpumping mechanism, rechargeable battery and control electronics insideeach milk collection hub, in much the same way as the Elvie Pump (see WO2018/229504) integrates an air pump, rechargeable battery and controlelectronics into an in-bra wearable unit that includes a user-attachablemilk collection container. The following features do not, unlessotherwise explicitly stated, require an external air pump, but should beexpansively construed to cover breast pump systems that can utilise anexternal or internal air pump. Similarly, whilst the implementationdescribed above is a breast pump system with a closed-loop air pump(i.e. the pump is protected from any possibility of milk contaminationthrough the flexible membrane), the following features do not, unlessotherwise explicitly stated, require a closed-loop air pump, but shouldbe expansively construed to cover breast pump systems that are bothclosed loop and also open loop.

A. User Experience Innovations: Nipple Visibility

Feature 1: Visibility of the Nipple

One implementation of this invention envisages a wearable milkcollection hub for a breast pump system that provides a clear andunobstructed view of the nipple for easy nipple alignment. This ensuresthat a correct alignment is maintained while pumping. The breast shieldand outer shells are both substantially clear providing a clear andunobstructed view of the nipple when the assembled system is placed onthe breast. This further enables the user to ensure proper nipplesuction when the breast pump system is placed on the breast and whilepumping.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the breast shield and the outer shell are substantiallytransparent, providing, to the mother placing the collection hub ontoher breast, a clear and unobstructed view of the nipple to facilitatecorrect nipple alignment.

Feature 2: Visibility of the Nipple and of the Flexible Diaphragm

In addition to the clear and unobstructed view of the nipple, the systemalso provides a clear and unobstructed view of the diaphragm inside thehub. A user is able to see any movement of the diaphragm while pumpingand ensure the system is correctly operating. The diaphragm is placed soas not to obstruct the line of sight to the nipple, hence providing botha view of the nipple and of the flexible diaphragm.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the breast shield and the outer shell are substantiallytransparent, providing simultaneously to the mother placing thecollection hub onto her breast (i) a clear and unobstructed view of thenipple to facilitate correct nipple alignment and (ii) a view of thediaphragm to ensure the breast pump system is operating correctly.

Feature 3: Visibility of the Nipple and of a Substantial Part of NippleTunnel

The system is also able to provide an unobstructed view of the nippletunnel for easy nipple alignment when the system is placed on the breastand while pumping. This further ensures that the spacing between thenipple and the side walls of the nipple tunnel is correctly positionedand maintained while pumping.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the breast shield and the outer shell are substantiallytransparent, providing to the mother placing the collection hub onto herbreast (i) a clear and unobstructed view of the nipple to facilitatecorrect nipple alignment and (ii) a clear and unobstructed view of asubstantial part of the nipple tunnel.

Feature 4: Diaphragm is Removably Mounted.

The wearable milk collection hub also includes a removable diaphragmthat is configured to separate the air pump side from the milk sidelocated in the hub, and thus prevents any contamination of the air pumpunit by any milk. The diaphragm is shaped so that it includes portionswhich are either substantially parallel to the center axis of the nippletunnel or substantially perpendicular to the center axis of the nippletunnel.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a substantially transparent breast shield made up of a        breast flange and a nipple tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) a substantially transparent outer shell that is configured        to removably attach to the breast shield, such that the breast        shield and outer shell form a vessel for collecting milk;

in which the diaphragm is removably mounted onto the breast shieldand/or the outer shell, and in which the diaphragm includes a portionthat is arranged over the end or tip of the nipple tunnel.

Feature 5: Specific Shape and Location of the Diaphragm

The diaphragm is also positioned so that it does not obstruct a mother'sview of the nipple when placing the collection hub onto her breast.Hence a mother is able to see any movement of the diaphragm when the airpump is activated, thereby further ensuring the proper function of thebreast pump system.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the diaphragm is removably mounted onto the breast shieldand/or the outer shell and is positioned behind a diaphragm cap thatforms part of the front or forward facing part of the outer shell, so asnot to obstruct a mother's view of the nipple when placing thecollection hub onto her breast.

B. Cost Engineering Innovations: Simplicity

Feature 6: Removable Diaphragm Cap

The wearable milk collection hub includes a removable diaphragm cap thatis configured to cover and seal the diaphragm. The diaphragm cap iseasily removable or attachable with a single push action when thecollection hub has been placed onto the breast. The diaphragm capincludes an air port or hole to connect a tube between the milkcollection hub and an external control unit housing a pump unitsubsystem.

Hence a mother can place the collection hub on her breast first withoutthe diaphragm cap and without the inconvenience of a tube connected tothe air port. Once the milk collection hub is correctly placed on thebreast, the mother can easily attach the diaphragm cap together with thetube with a single push action.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the outer shell includes a removable diaphragm cap that coversand seals the diaphragm; and in which the diaphragm cap forms part ofthe front or forward facing part of the outer shell and includes an airport configured to transfer negative air pressure from the external airpump subsystem to the diaphragm.

Feature 7: Removable Diaphragm Cap is Omnidirectional

A further advantage of the diaphragm cap is that it is omnidirectionaland can be easily rotated on the rear surface of the outer shell,therefore providing the user with the ability to change or rotate theposition of the air port on the diaphragm cap. This also helps the usermodify the placement of a tube connected to the diaphragm cap. Thisfeature also provides added versatility and/or flexibility to be used bydifferent users and body shape with different clothing to achievecomfort and/or discretion.

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;

in which the outer shell includes a removable diaphragm cap that coversand seals the diaphragm; and in which the diaphragm cap forms part ofthe front or forward facing part of the outer shell and includes an airport configured to transfer negative air pressure from the external airpump subsystem to the diaphragm; and in which the removable diaphragmcap is configured to rotate to enable the position of the air port onthe outer shell to be adjusted by a user.

Feature 8: 3 User-Removable Parts from the Breast Shield

We can generalize to:

A wearable milk collection hub for a breast pump system comprising:

-   -   (a) a breast shield made up of a breast flange and a nipple        tunnel;    -   (b) a flexible diaphragm that is configured to prevent milk from        reaching an external air pump subsystem;    -   (c) an outer shell that is configured to removably attach to the        breast shield, such that the breast shield and outer shell form        a vessel for collecting milk;    -   (d) a diaphragm cap that forms part of the front or forward        facing part of the outer shell;

and in which the only user removable items from the breast shield are:the outer shell, the diaphragm, and the diaphragm cap, in normal use ornormal disassembly.

C. User Experience Innovations: Low Noise

Feature 9: Airflow Block

We can generalize to:

A control unit for generating negative air pressure for a breast pumpsystem, the control unit including:

-   -   (a) a rechargeable battery;    -   (b) a power charging circuit for controlling the charging of the        rechargeable battery;    -   (c) control electronics powered by the rechargeable battery;    -   (d) a pump powered by the rechargeable battery and generating        negative air pressure; and    -   (e) a motor for driving the pump;    -   (f) a casing;    -   in which the control unit further includes an airflow block that        is configured to transfer suction from the pump to a suction or        air port on the control unit and is further configured to        attenuate sound from the pump and/or the motor reaching from        reaching the casing.

Feature 10: Sound Valve

We can generalize to:

A control unit for generating negative air pressure for a breast pumpsystem, the control unit including:

-   -   (a) a rechargeable battery;    -   (b) a power charging circuit for controlling the charging of the        rechargeable battery;    -   (c) control electronics powered by the rechargeable battery;    -   (d) a pump powered by the rechargeable battery and generating        negative air pressure; and    -   (e) a motor for driving the pump;    -   and in which the control unit further includes a sound valve        that is configured to air to pass in and out of the control unit        sufficient for pressure equalisation between the inside and        outside of the control unit, while minimizing sound from the        pump and/or motor escaping from the control unit.

Feature 11: Solenoid Foam Cap

We can generalize to:

A control unit for generating negative air pressure for a breast pumpsystem, the control unit including:

-   -   (a) a rechargeable battery;    -   (b) a power charging circuit for controlling the charging of the        rechargeable battery;    -   (c) control electronics powered by the rechargeable battery;    -   (d) a pump powered by the rechargeable battery and generating        negative air pressure and;    -   (e) a motor for driving the pump;    -   (f) a solenoid valve for controlling the generated negative air        pressure;    -   and in which the control unit further includes a cap or other        structure that is configured to reduce the speed of air that        enters the solenoid valve when the solenoid valve opens to        ambient air pressure.

D. User Experience Innovations: Product Handling

Feature 12: Multifunction Mount

We can generalize to:

A control unit for generating negative air pressure for a breast pumpsystem, the control unit including:

-   -   (a) a rechargeable battery;    -   (b) a power charging circuit for controlling the charging of the        rechargeable battery;    -   (c) control electronics powered by the rechargeable battery;    -   (d) a pump powered by the rechargeable battery and generating        negative air pressure and;    -   (e) a motor for driving the pump;    -   and in which the control unit further includes a removable        multifunction mount configured to attach to the control unit in        at least two different positions, such that the control unit can        be held in either upright/portrait or longwise/landscape mode.

Feature 13: Tube Management Feature

We can generalize to:

A control unit for generating negative air pressure for a breast pumpsystem, the control unit including:

-   -   (a) a rechargeable battery;    -   (b) a power charging circuit for controlling the charging of the        rechargeable battery;    -   (c) control electronics powered by the rechargeable battery;    -   (d) a pump powered by the rechargeable battery and generating        negative air pressure and;    -   (e) a motor for driving the pump;    -   and in which the control unit further includes or, is removably        attached to a tube management structure configured to enable an        air tube attachable to the control unit to be wound around that        tube management structure.

Generally applicable optional features that can be combined with any oneor more of the above features and can themselves be combined with oneanother:

Breast Shield

-   -   breast shield is rigid or semi-rigid.    -   breast shield is made up of a breast flange and a nipple tunnel;        in which the nipple tunnel is configured to receive a nipple.    -   breast shield comes in different sizes, each of which are        configured to attach to the same outer shell.    -   different sizes of the breast shield each provide a different        spacing of the nipple from side walls of the nipple tunnel, when        the breast shield is positioned onto a breast.    -   breast shield integrates the breast flange and nipple tunnel as        a single one-piece item with no joins.    -   nipple tunnel includes a milk hole through which express milk        flows into the milk collection hub via a non return valve.    -   breast shield includes a diaphragm housing that has sides that        are parallel to the nipple tunnel.    -   diaphragm housing includes an air hole that transfers negative        air pressure to the nipple tunnel.    -   air-pump chamber is a substantially annular chamber with walls        that are parallel to the long or central axis of the nipple        tunnel and those parallel walls lie over a region of the nipple        tunnel that is subject in use to negative air pressure.    -   diaphragm housing has an outer, approximately cylindrical side        wall that is generally parallel to the nipple tunnel, and an        inner, approximately cylindrical side wall that is also is        generally parallel to the nipple tunnel.    -   diaphragm housing has a front wall that forms the end of the        nipple tunnel.    -   diaphragm housing has an annular rear wall that joins the outer        and the inner sides walls and that annular rear wall lies over a        region of the nipple tunnel that is subject in use to negative        air pressure.    -   diaphragm moves within an air-pump chamber formed on one side by        the diaphragm housing with walls that are parallel to the long        or central axis of the nipple tunnel and on another side by the        diaphragm cap.    -   breast shield is integrated with the diaphragm housing portion        as a single, one piece moulded item.    -   breast shield includes a removable perimeter seal that provides        an air-tight seal between an outer edge of the breast shield and        the outer shell.    -   breast shield is a transparent or optically clear, dishwasher        safe polypropylene, polycarbonate or copolyester, such as        Tritan™, breast shield.

Outer Shell

-   -   outer shell is rigid.    -   the outer shell removably attaches, fits or latches onto the        breast shield and so the breast shield provides a rear surface        that is in contact with milk.    -   outer shell is attachable to the breast shield with a single        push action.    -   outer shell attaches to the breast shield using magnets.    -   outer shell includes an air opening or vent hole such that        atmospheric pressure is maintained inside the milk collection        hub.    -   outer shell is directly removable from the breast shield in        normal use or normal dis-assembly    -   outer shell is removable from the breast shield together with a        flexible diaphragm that is attached, permanently or removably,        to the outer shell.    -   outer shell is an integral part of the breast shield.    -   outer shell includes a diaphragm cap that sits over a diaphragm.    -   outer shell and diaphragm are together a single item.    -   outer shell includes a pouring opening which can be closed for        transportation of the milk collection hub.    -   outer shell has a front surface that is curved to fit inside a        bra and to contact the inner surface of the bra.    -   outer shell is a transparent or optically clear, dishwasher safe        polypropylene, polycarbonate or copolyester, such as Tritan™,        outer shell.    -   outer shell is a self-contained milk collection hub and so the        breast shield does not provide a surface in contact with milk.

Diaphragm

-   -   diaphragm is flexible, and deforms to create negative pressure.    -   diaphragm is not sufficiently flexible to deform to create        negative pressure but serves instead solely to prevent milk from        passing through it and filling the air lines or reaching the        motor.    -   diaphragm is substantially rigid and serves instead solely to        prevent milk from passing through it and filling the air lines        or reaching the motor.    -   diaphragm includes inner and outer side walls that are        substantially parallel to the center axis of the nipple tunnel.    -   diaphragm includes substantially cylindrical inner and outer        side walls that are substantially parallel to the center axis of        the nipple tunnel.    -   diaphragm, when under negative pressure, moves past a milk        opening in the nipple tunnel towards the over the end or tip of        the nipple tunnel.    -   diaphragm includes portions which are substantially parallel to        the center axis of the nipple tunnel and includes portions which        are substantially perpendicular to the center axis of the nipple        tunnel.    -   diaphragm is shaped to be flush to a diaphragm housing that has        an outer, approximately cylindrical side wall that is generally        parallel to the nipple tunnel, and an inner, approximately        cylindrical concentric side wall that is also is generally        parallel to the nipple tunnel.    -   diaphragm flexes when negative air pressure is applied to it by        an air pump subsystem, and transfers that negative air-pressure        to pull the breast and/or nipple against the breast shield to        cause milk to be expressed.    -   diaphragm is positioned such as not to obstruct a mother's view        of a substantial part of the nipple tunnel when placing the        collection hub onto her breast;    -   diaphragm is moulded as part of, or otherwise attached to, the        outer shell.    -   the outer shell and diaphragm are formed or joined together to        form a single item.    -   diaphragm includes portions that run substantially parallel to        the center axis of the nipple tunnel.    -   diaphragm is a single flexible membrane shaped to include inner        and outer substantially cylindrical walls that are generally        parallel to the center axis of the nipple tunnel.    -   diaphragm includes a portion that sits over the end of the        nipple tunnel, facing away from the breast.    -   diaphragm is removably attached to the outer shell.    -   diaphragm is removable from the outer shell for cleaning    -   diaphragm is configured to self-seal under the negative air        pressure to a    -   diaphragm holder that is part of the breast shield.    -   diaphragm is a one-piece item devoid of any holes or openings.    -   diaphragm is permanently fixed to the outer shell.    -   diaphragm is a single flexible membrane shaped to include inner        and outer substantially cylindrical walls that are generally        parallel to the center axis of the nipple tunnel, an annular        wall that joins the inner and outer substantially cylindrical        walls, and an end wall that sits over the end of the nipple        tunnel.

Diaphragm Cap

-   -   diaphragm cap is removable.    -   diaphragm cap forms the front of the outer shell.    -   diaphragm cap includes an air port that is configured to deliver        air pressure to the milk collection hub.    -   diaphragm cap is configured to fit or latch onto the outer shell        with a single push action.    -   diaphragm cap includes recesses or features configured to be        gripped with the fingers of one hand.    -   diaphragm cap includes a pair of recesses configured to enable        the cap to be gripped and removed from the outer shell, and        installed into the outer shell, with a single hand.    -   diaphragm cap is rotatable in the outer shell to adjust the        position of the air port on the diaphragm cap.    -   diaphragm cap includes a passage way for the air tube.    -   diaphragm cap includes a flat portion such that the milk        collection hub can rest on a flat surface positioned on this        flat portion.    -   diaphragm cap is is shaped to fit inside an inner portion of a        bra.    -   diaphragm cap is a transparent or optically clear, dishwasher        safe polypropylene, polycarbonate or copolyester, such as        Tritan™, diaphragm cap.

Entire System

-   -   the system is a closed system.    -   the system has a capacity of approximately 5 fluid ounces (148        ml).    -   width of the milk collection hub is of about 5.7 cm in the        direction of the central axis of the nipple tunnel.    -   each milk collection hub is, in-use, bra-worn, for example is        shaped to be worn inside a maternity bra.    -   the system makes less than 50 dB noise at maximum power when the        motor is running, and preferably less than 45 dB.

Control Unit

-   -   control unit is configured to control suction delivered to one        or two wearable milk collection hubs.    -   control unit houses an air pump subsystem that is configured to        generate negative air pressure and transfer negative air        pressure to a wearable milk collection hub.    -   control unit does not house an air pump subsystem but controls        an air pump that is external to the control unit    -   air pump subsystem is held in place between a sound attenuating        motor mount and an airflow block, each configured to absorb        vibration from the pump unit.    -   control unit includes a wireless data communications system        powered by a rechargeable battery;    -   control unit includes one or more buttons which are configured        to control at least one wearable collection hub.    -   control unit includes a visual and/or haptic indicator that        indicates whether milk is flowing or not flowing into the hub.    -   control unit includes a visual and/or haptic indicator that        indicates the activated pumping profile or pattern.    -   control unit includes a visual and/or haptic indicator that        indicates the rechargeable battery status.    -   control unit includes a USB charging socket connected to the        power charging circuit;    -   multifunction mount is an o-ring.

Airflow Block

-   -   airflow block is configured transfer air or suction from the        pump unit and also to absorb vibrations from the pump unit.    -   airflow block is made of a compression moulded silicone.    -   airflow block is directly connected to the air pump subsystem        outlet.    -   airflow block is located near a solenoid valve.    -   airflow block is a one-piece item.    -   control unit is sealed such as to further attenuate sound.    -   control unit includes an housing with a top portion and a bottom        portion.    -   the bottom and top portions are sealed together using a seal        perimeter.    -   airflow block is integrated with a portion of the seal        perimeter.    -   airflow block connects to an air port or hole for a tube that        delivers air to a wearable milk collection hub.

Sound Valve

-   -   sound valve is configured to regulate the pressure inside the        control unit so that the inside of the control unit remains at        ambient pressure and also to attenuate noise from the pump unit        escaping from inside the control unit.    -   sound valve is located on the bottom portion of the control        unit.    -   sound valve includes a small cut that is configured to deform        under pressure.    -   sound valve is made of silicone.

Foam Cap

-   -   solenoid foam cap is configured to reduce the speed of air that        enters the solenoid valve when the solenoid valve opens to        ambient air pressure and hence to reduce the sound of that air        entering the solenoid valve.    -   solenoid foam cap is a one piece item made of plastic.    -   foam cap includes one or more small opening or holes.    -   control unit also includes two silencers (or muffler) in which        one silencer is connected to the solenoid valve and the other        silencer is connected to the motor.

Note

It is to be understood that the above-referenced arrangements are onlyillustrative of the application for the principles of the presentinvention. Numerous modifications and alternative arrangements can bedevised without departing from the spirit and scope of the presentinvention. While the present invention has been shown in the drawingsand fully described above with particularity and detail in connectionwith what is presently deemed to be the most practical and preferredexample(s) of the invention, it will be apparent to those of ordinaryskill in the art that numerous modifications can be made withoutdeparting from the principles and concepts of the invention as set forthherein.

A portion of the disclosure of this patent document contains material,which is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever.

What is claimed is:
 1. A wearable milk collection hub comprising: abreast shield comprising: a breast flange; a nipple tunnel extendingfrom the breast flange, the nipple tunnel comprising a closed end and amilk port, the milk port being intermediate to the breast flange and theclosed end; and an outer edge; a diaphragm configured to deform tocreate negative air pressure in the nipple tunnel, the diaphragm beingat least partially arranged over the closed end of the nipple tunnel;and an outer shell comprising an outer groove configured to receive theouter edge of the breast shield such that the outer shell is configuredto be removably attachable to the breast shield, the outer shell furtherconfigured to receive expressed milk via the milk port.
 2. The wearablemilk collection hub of claim 1, wherein the outer shell is configured tobe removably attachable to the breast shield such that the outer shellis configured to contact the breast shield at a rear end of the outershell and the breast shield is configured to contact the expressed milkat a front end of the breast shield.
 3. The wearable milk collection hubof claim 1, wherein the outer shell comprises a top end comprising apouring opening configured to release the expressed milk.
 4. Thewearable milk collection hub of claim 1, wherein the outer shellcomprises a base comprising a flat portion configured to allow thewearable milk collection hub to rest on a flat surface.
 5. The wearablemilk collection hub of claim 1, wherein the breast shield comprises adiaphragm housing part comprising an air hole configured to transfernegative air pressure to the nipple tunnel.
 6. The wearable milkcollection hub of claim 1, wherein the diaphragm is configured to beremovably mounted between the breast shield and the outer shell.
 7. Thewearable milk collection hub of claim 1, wherein the breast shield andthe outer shell are substantially transparent, providing, to the motherplacing the wearable milk collection hub onto her breast a view of thenipple to facilitate correct nipple alignment, and wherein the outershell is configured to support an air port configured to provide an airconnection to a control unit via a tube, the air port being disposedthrough an opaque portion of the wearable milk collection hub.
 8. Awearable milk collection hub configured to connect to an externalnegative pressure generating control unit comprising: a breast shieldcomprising: a breast flange; a nipple tunnel extending from the breastflange, the nipple tunnel comprising an end remote from the breastflange and a milk port intermediate to the breast flange and the end;and a diaphragm housing part; a diaphragm configured to be removablymounted to the diaphragm housing part, and to deform based on negativeair pressure generated by the control unit to create negative airpressure in the nipple tunnel; and an outer shell comprising a rear endconfigured to removably attach the outer shell to the breast shield suchthat the breast shield and the outer shell form a vessel to receiveexpressed milk via the milk port, a front end opposing the rear end, thefront end comprising a curvature, a base intermediate to the rear endand the front end, the base comprising a flat portion configured toallow the wearable milk collection hub to rest on a flat surface, and atop end opposing the base, the top end comprising a pouring openingconfigured to release the expressed milk.
 9. The wearable milkcollection hub of claim 8, wherein a structure comprising the diaphragmis configured to be at least partially arranged over the closed end ofthe nipple tunnel.
 10. The wearable milk collection hub of claim 8,further comprising an air port configured to provide an air connectionto the control unit via a tube.
 11. The wearable milk collection hub ofclaim 10, further comprising a movable cap positioned over the air port.12. The wearable milk collection hub of claim 11, wherein the movablecap is disposed on a front end of the outer shell.
 13. The wearable milkcollection hub of claim 8, wherein the breast shield and the outer shellare substantially transparent, providing, to the mother placing thewearable milk collection hub onto her breast a view of the nipple tofacilitate correct nipple alignment, and wherein the wearable milkcollection hub is shaped to be worn inside a bra.
 14. The wearable milkcollection hub of claim 8, wherein the rear end of the outer shell isconfigured to receive an outer edge of the breast shield such that anair-tight seal is formed between the breast shield and the outer shell.15. The wearable milk collection hub of claim 8, wherein the breastshield is semi-rigid.
 16. A breast pump system comprising: a controlunit comprising: a battery, and a pump configured to be powered by thebattery and to generate negative air pressure; and a wearable milkcollection hub configured to connect to the control unit via an airline, the wearable milk collection hub comprising: a breast shieldcomprising: a breast flange; a nipple tunnel extending from the breastflange, the nipple tunnel comprising a closed end and a milk portintermediate to the breast flange and the closed end; and a diaphragmhousing part; a diaphragm configured to be removably mounted to thediaphragm housing part, and to deform based on the negative air pressuregenerated by the pump to create negative air pressure in the nippletunnel; and an outer shell comprising a rear end configured to removablyattach to the breast shield, an interior volume between the outer shelland the breast shield defining a chamber to receive expressed milk viathe milk port.
 17. The wearable milk collection hub of claim 16, whereinthe diaphragm housing part is disposed between the breast shield and theouter shell such that the diaphragm is configured to be removablymounted between the breast shield and the outer shell.
 18. The wearablemilk collection hub of claim 16, wherein the breast shield comprises anouter edge configured to be received by the rear end of the outer shell.19. The wearable milk collection hub of claim 16, wherein the interiorvolume is bounded by the rear end of the outer shell and a front end ofthe breast shield.
 20. The wearable milk collection hub of claim 16,wherein the control unit further comprises: a wireless datacommunications system configured to be powered by the battery; one ormore buttons configured to control the wearable milk collection hub; atleast one of a visual indicator or a haptic indicator configured toindicate the activated pumping profile or pattern; at least one of avisual indicator or a haptic indicator configured to indicate a statusof the battery; and a Universal Serial Bus (USB) charging socketconfigured to be connected to a power charging circuit.